“Anecdotal experience from Grunenthal’s Zalviso launch that began in April has been favorable, with patients and healthcare workers providing positive feedback on the pain control offered by sublingual sufentanil,” commented Howie Rosen , AcelRx’s chief executive officer. “We look forward to conducting the IAP312 study and submitting the findings to the FDA so that they may consider the product for approval here in the U.S.We will provide an update on study duration once we are further along with enrollment.” Three Phase 3 studies for Zalviso in a total of 768 patients have been completed to date: IAP309, IAP310 and IAP311, detailed information for which may be found on www.clinicaltrials.gov . In brief, IAP309 was a Phase3 open-label, active comparator study, in which Zalviso was shown to be non-inferior (p<0.001), as well as superior (p=0.007), to intravenous (IV) PCA morphine based on the primary endpoint of Patient Global Assessment method of pain control comparison over the 48-hour trial period (PGA48). IAP310 and IAP311 were Phase 3 double-blind, placebo-controlled studies in which patients treated with Zalviso to manage their post-operative pain reported a greater summed pain intensity difference to baseline over 48 hours (SPID48, the primary endpoint) compared to placebo-treated patients (p=0.001 and p<0.001, respectively). The most common adverse events experienced by patients using Zalviso in these clinical studies were nausea, pyrexia (fever) and vomiting. "We designed Zalviso to have characteristics that would offer patients and healthcare providers benefits over IV morphine, the current standard of care for the treatment of moderate-to-severe acute pain in hospitalized patients," concluded Dr. Pamela Palmer , AcelRx's co-founder and chief medical officer. http://sandiegosunfire.com/sandiegosunfirecom2755/2016/09/21/mid-substance-tendonitis-provides-as-an-unpleasant-swelling-of-the-tendon-as-well-as-is-commonly-seen-in-long-distance-joggers/“The initiation of IAP312 is an important milestone, as it represents what we expect to be the last step in the Zalviso clinical development program, bringing a product that we believe can offer patients a new option for treating their moderate-to-severe acute pain, closer to market.” About AcelRx Pharmaceuticals, Inc. AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain.
For the original version including any supplementary images or video, visit http://finance.yahoo.com/news/acelrx-initiates-phase-3-study-110000355.html
He.s also confused, believing Nagato to have been very firm in his convictions and thus not likely to give up so willingly. The relative intensities of pain, then, may resemble the relative importance of that risk to our ancestors lack of food, too much cold, or serious injuries are felt as agony, whereas minor damage is felt as mere discomfort. Pain that lasts a long time is called chronic or persistent, and pain that resolves quickly is called acute . He regained some of his former mobility after being reincarnated and taking some of the Eight-Tails ‘ chakra. Epifanio Bagarinao, Kevin A. She takes Nagato’s and Yahiko’s bodies back to Amegakure and creates a secret shrine for them, laying their bodies on beds of flowers. When he met Yahiko he tried to break this habit by following Yahiko’s philosophy that crying wouldn’t change anything, but the attempt was unsuccessful. http://foresthillmotel.com/askryanwashington/2016/09/21/honestly-i-have-a-little-revenge-in-me-to-win-a-state-and-public-league-championship-he-said/It is a disorder characterized by fatigue, sleep disturbances, stiffness, tender points, joint tenderness, and widespread muscle pain.
You may also be interested to read
- Full Report